Why FDA's OOS Expectations Exist: The Barr Laboratories Case
Why FDA expects strict OOS handling: the 1993 Barr Laboratories ruling on retesting, averaging and outlier tests, and how it shaped FDA's OOS guidance.
Regulatory Affairs
What Is Data Integrity in the Pharmaceutical Industry?
What is data integrity in pharma? Learn the MHRA and FDA definitions, ALCOA and ALCOA+ principles, data governance and audit trail basics for QA and QC teams.
Stability Testing: Why It Matters, Climatic Zones and Conditions
Why stability testing matters in pharma: ICH Q1A(R2) and WHO TRS 1010 storage conditions, climatic zones I to IVb, and the status of the new consolidated ICH Q1.